Abiraterone acetate and prednisolone for metastatic castration-resistant prostate cancer failing androgen deprivation and docetaxel-based chemotherapy: A phase II bridging study in Korean and Taiwanese patients

作者：Kwak Cheol^*; Wu Tony Tong Lin; Lee Hyun Moo; Wu Hsi Chin; Hong Sung Joon; Ou Yen Chuan; Byun Seok Soo; Rhim Hyou Young; Kheoh Thian; Wan Ying; Yeh Howard; Yu Margaret K; Kim Choung Soo

来源：International Journal of Urology, 2014, 21(12): 1239-1244.

DOI：10.1111/iju.12589

• abiraterone acetate
• docetaxel
• metastatic castration-resistant prostate cancer
• prednisolone
• prostate-specific antigen

ObjectivesTo evaluate the safety and efficacy of abiraterone acetate and prednisolone in Korean and Taiwanese patients with metastatic castration-resistant prostate cancer not responding to docetaxel-based chemotherapy. %26lt;br%26gt;MethodsIn this single-arm study, 82 metastatic castration-resistant prostate cancer patients who failed docetaxel-based chemotherapy were treated with abiraterone (1000mg, once daily) and prednisolone (5mg, twice daily). Patients achieving a prostate-specific antigen decline 50% were considered as responding. %26lt;br%26gt;ResultsA total of 35 patients (43%) achieved prostate-specific antigen response (95% confidence interval 32-54). The median time to prostate-specific antigen progression was 4.7months (95% confidence interval 3.7-8.3); the median overall survival was 11.8months. Two (4%) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725mol/L (baseline) to 0.080mol/L (cycle4). The most common adverse event was bone pain (20%); grade3/4 adverse event of special interest were hypokalemia (7%), fluid retention and liver function abnormalities (5% each), hypertension (2%), and cardiac disorders (1%). %26lt;br%26gt;ConclusionsA combination of abiraterone acetate and prednisolone appears to be a favorable second-line treatment in Taiwanese and Korean patients with advanced metastatic castration-resistant prostate cancer after failed docetaxel-based chemotherapy.

• 出版日期2014-12
• 单位中国医科大学